Manufacturing: Page 42
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Pfizer temporarily shutters Indian facility after inspections
Acquired in last year's Hospira deal, the site near Chennai had previously been flagged by U.S. regulators in 2013 for manufacturing violations.
By Ned Pagliarulo • Aug. 9, 2016 -
Deep Dive
Seizing CAR-T lead, Kite readies commercial-scale manufacturing
Along with safety, the ability to quickly manufacture the first wave of CAR-T therapies will likely be a key test of commercial viability.
By Ned Pagliarulo • Aug. 9, 2016 -
Pfizer cuts 151 jobs at New York plant
The cuts to the Pearl River site come as Pfizer expands its manufacturing operations elsewhere.
By Ned Pagliarulo • Aug. 4, 2016 -
Teva bolsters generics consolidation with purchase of Allergan's distributor
Teva will pay Allergan $500 million for Anda Inc., the fourth largest wholesale distributor of generics in the U.S.
By Edwin Lopez • Aug. 4, 2016 -
Chinese drug manufacturer lies to FDA, promptly gets banned
In a particularly deadpan warning letter to Xiamen Origin Biotech, the FDA slammed the API producer for misleading customers and lying to a FDA inspector.
By Nicole Gray , Ned Pagliarulo • Aug. 4, 2016 -
Keryx says Auryxia shortage 'imminent'
The company has announced that their phosphate binder Auryxia will not be available until Q4.
By Nicole Gray • Aug. 4, 2016 -
Takeda hones R&D focus in $725 million restructuring
The company plans to build out three R&D hubs in the U.S. and Japan, aimed at underpinning a more global approach to partnering and collaboration.
By Edwin Lopez • July 29, 2016 -
Teva will provide long-term API contracts to producers in 15 markets
U.S. regulators set the condition to ensure Teva does not use API supply contracts to force competitors to raise product prices.
By Edwin Lopez • July 28, 2016 -
GSK to invest $360 million in UK plants despite Brexit vote
The spending might help ease concerns about Britain's future as a pharma hub.
By Randy Lilleston • July 28, 2016 -
Shnaghai Fosun to buy large stake in Gland Pharma for $1.4 billion
This acquisition represents the first major purchase of an Indian manufacturing outfit by a Chinese firm.
By Nicole Gray • July 28, 2016 -
EU regulator recommends market suspension for dozens of generics
The European Medicines Agency concluded bioequivalence studies conducted by an India-based contract researcher to support generic approvals were "flawed."
By Edwin Lopez • July 25, 2016 -
Pfizer presses on with expansion of Irish manufacturing site
When completed, the build-out is expected to add up to 350 jobs at the Grange Castle site, according to a new report.
By Nicole Gray • July 21, 2016 -
Merck KGaA building $115 million life science facility in MA
The new MiliporeSigma facility will house the M Lab Collaboration Center, one of nine such hubs planned for construction worldwide.
By Nicole Gray • July 21, 2016 -
Glaxo failed to resolve contamination at UK plant, FDA says
The FDA "strongly urged" Glaxo to dedicate the site to only penicillin production in light of repeated contamination problems.
By Edwin Lopez • July 20, 2016 -
Cipla invests $90 million in South African biosim plant
Only 2% of patients in Africa have access to biologics, according to the Indian drugmaker.
By Nicole Gray • July 14, 2016 -
GE Healthcare ventures into cell therapy supply space
Eyeing a potential $1 billion opportunity, General Electric's health unit just snapped up a Switzerland-based cell bioprocessing systems supplier.
By Edwin Lopez • July 14, 2016 -
Drug manufacturer Patheon plans major IPO to pay down debt
The company expects to list 30.5 million shares on the New York Stock Exchange.
By Nicole Gray • July 11, 2016 -
Pfizer planning expansion of Irish manufacturing facility
The planned move would further expand Pfizer's presence in Ireland, even after its failed relocation attempt.
By Nicole Gray • July 7, 2016 -
3-D drug firm Aprecia wins another $30 million in venture-funded debt
Aprecia aims to advance its pipeline and commercialize Spritam, the first 3-D drug approved by the FDA.
By Nicole Gray • July 7, 2016 -
Five NCI cell therapy studies resume production after April halt
Lion Biotechnologies' three affiliated studies were resumed, but Kite's four studies remain suspended.
By Edwin Lopez • July 7, 2016 -
With insulin market set for shake-up, Novo Nordisk expands production plant
The Danish company will invest nearly $60 million in its large Kalundborg facility.
By Nicole Gray • July 5, 2016 -
InVentiv Health comes on board as Pfizer's fourth CRO
Pfizer's other three preferred-provider contract research organizations are Icon, Parexel and PPD.
By Nicole Gray • June 30, 2016 -
Icagen to buy Sanofi lab, widening R&D reach
As part of the deal, Icagen will also manage the site's "extensive" library of drug compounds.
By Nicole Gray • June 30, 2016 -
Pfizer to open first Asia biotech center in China
Located in Hangzhou, the $350 million facility will eventually produce biosimilar drugs for both Chinese and global markets.
By Ned Pagliarulo • June 28, 2016 -
Pfizer plans to close Colorado production facility
Acquired when Pfizer bought Hospira last year, the site currently employs around 100 people.
By Ned Pagliarulo • June 23, 2016